NCT00500487

Brief Summary

Adolescents are at risk for HIV because of sexual and drug behavior intiated during this developmental period. Those with psychological distress are less likely than their peers to benefit from frequently used skills-based interventions. It appears that emotional lability during sexual situations disrupts skills learned. This project will implement and evaluate interventions for adolescents with psychiatric disorders who are in therapeutic school settings. Affect management and skills-based interventions will be compared to a didactic standard of care condition to determine which intervention best reduces risk behavior among adolescents with psychiatric disorders in therapeutic school settings.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
420

participants targeted

Target at P75+ for phase_1 hiv-infections

Timeline
Completed

Started Apr 2003

Longer than P75 for phase_1 hiv-infections

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2003

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

July 11, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 12, 2007

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

January 12, 2015

Status Verified

October 1, 2009

Enrollment Period

7.2 years

First QC Date

July 11, 2007

Last Update Submit

January 9, 2015

Conditions

Keywords

HIV preventionHIV seronegativity

Outcome Measures

Primary Outcomes (1)

  • Adolescent-reported condom use

    1 year

Study Arms (3)

1

EXPERIMENTAL
Behavioral: Affect Management

2

ACTIVE COMPARATOR
Behavioral: HIV Prevention Skills

3

ACTIVE COMPARATOR
Behavioral: General Health Promotion

Interventions

12-session group intervention including affect management training as well as sexual health skills training.

1

12-session group intervention including sexual health skills training.

2

12-session group intervention including health information on a variety of health topics.

3

Eligibility Criteria

Age13 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Adolescent attending therapeutic school

You may not qualify if:

  • Adolescent is HIV positive
  • Adolescent is developmentally delayed
  • Adolescent is pregnant
  • Adolescent has a history of sexual crime

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Related Publications (1)

  • Brown LK, Whiteley L, Houck CD, Craker LK, Lowery A, Beausoleil N, Donenberg G. The Role of Affect Management for HIV Risk Reduction for Youth in Alternative Schools. J Am Acad Child Adolesc Psychiatry. 2017 Jun;56(6):524-531. doi: 10.1016/j.jaac.2017.03.010. Epub 2017 Mar 31.

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Larry K Brown, MD

    Rhode Island Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2007

First Posted

July 12, 2007

Study Start

April 1, 2003

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

January 12, 2015

Record last verified: 2009-10

Locations